The consolidated financial statements, included elsewhere in this Quarterly Report on Form 10-Q, and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read together with our audited financial statements and accompanying notes for year endedDecember 31, 2021 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, both of which are included in our Annual Report on Form 10-K. In addition to historical information, this discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. As disclosed in this report under "Cautionary Note Regarding Forward-Looking Statements," our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" sections contained in our Annual Report on Form 10-K for the year endedDecember 31, 2021 and our Form 10-Q for the quarter endedMarch 31, 2022 . Our operating results are not necessarily indicative of results that may occur for the full fiscal year or any other future period.
On
Our Focus. We are a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Our lead product candidate, resmetirom, is a proprietary, liver-directed, selective thyroid hormone receptor-ß, or THR-ß, agonist being developed as a once-daily oral pill that can potentially be used to treat NASH and a number of disease states with high unmet medical need. Our Patient Market Opportunity. NASH is a serious inflammatory form of nonalcoholic fatty liver disease, or NAFLD. NAFLD has become the most common liver disease inthe United States and other developed countries and is characterized by an accumulation of fat in the liver with no other apparent causes. NASH can progress to cirrhosis or liver failure, require liver transplantation and can also result in liver cancer. Progression of NASH to end stage liver disease will soon surpass all other causes of liver failure requiring liver transplantation. Importantly, beyond these critical conditions, NASH and NAFLD patients additionally suffer heightened cardiovascular risk and, in fact, die more frequently from cardiovascular events than from liver disease. NASH and NAFLD have grown as a consequence of rising worldwide obesity-related disorders. Inthe United States , NAFLD is estimated to affect approximately 25% of the population, and approximately 25% of those will progress from NAFLD to NASH. Current estimates place NASH prevalence at approximately 20 million people inthe United States , or five to six percent of the adult population, with similar prevalence inEurope andAsia . The prevalence of NASH is also increasing in developing regions due to the adoption of a more sedentary lifestyle and a diet consisting of processed foods with high fat and fructose content. Our Completed Studies. For NASH, we enrolled 125 patients in a Phase 2 clinical trial with resmetirom. We achieved the 12-week primary endpoint for this Phase 2 clinical trial and reported the results inDecember 2017 , and we reported positive topline 36-week results at the conclusion of the Phase 2 clinical trial inMay 2018 . We also completed a 36-week, open-label extension study in 31 participating NASH patients from our Phase 2 clinical trial, which included 14 patients who received placebo in the main study. OnDecember 18, 2019 the Company announced it had opened for enrollment MAESTRO-NAFLD-1, a 52-week, non-invasive, multi-center, double-blind, placebo-controlled Phase 3 clinical study of patients with biopsy-confirmed or presumed NASH recruited from sites in theU.S. Key endpoints are safety, including safety biomarkers. Secondary endpoints include LDL cholesterol, lipid biomarkers, MRI-PDFF, NASH and fibrosis biomarkers. Except for serial liver biopsies, the study protocol is similar to the MAESTRO-NASH study (discussed below under "-Our Ongoing and Planned Studies"), with resmetirom doses of 80 mg or 100 mg or placebo. Enrollment objectives for this study were exceeded, with approximately 1,300 patients enrolled overall. The MAESTRO-NAFLD-1 study will help support the adequacy of the safety database at the time of NDA submission for Subpart H approval for treatment of NASH in patients with F2 or F3 fibrosis. In November of 2021, we reported data from the open label non-cirrhotic arm of MAESTRO-NAFLD-1, and inJanuary 2022 we announced that we achieved primary and secondary endpoints for the double-blind portion of MAESTRO-NAFLD-1. Further MAESTRO-NAFLD-1 data were presented at a hepatology medical congress in June of 2022. MAESTRO-NAFLD-1 has completed the double-blind arms and an open-label 100 mg arm. An additional open-label active treatment arm in patients with early (well-compensated) NASH cirrhosis is ongoing. We also completed a 116 patient Phase 2 clinical trial and announced results inFebruary 2018 for the use of resmetirom in patients with heterozygous familial hypercholesterolemia, or HeFH. In addition to the NASH and HeFH Phase 2 clinical trials, resmetirom has also been studied in multiple completed Phase 1 trials in a total of more than 300 subjects. Resmetirom was well-tolerated in these trials, which included a single ascending dose trial, a multiple ascending dose trial, several drug interaction studies, a multiple dose mass balance study, a single dose relative bioavailability study of tablet formulation versus capsule formulation, a multiple dose drug interaction study, a multiple dose drug interaction with food effect study, and a hepatic impairment study. 19
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Our Ongoing and Planned Studies. OnMarch 28, 2019 , the Company announced that it had initiated MAESTRO-NASH, a Phase 3 trial in NASH with its once daily, oral thyroid hormone receptor beta selective agonist, resmetirom. This double-blind, placebo-controlled study is being conducted at more than 230 sites inthe United States and the rest of the world. Patients with liver biopsy confirmed NASH with stage 2 or 3 fibrosis are being randomized 1:1:1 to receive a single oral daily dose of placebo, resmetirom 80 mg or resmetirom 100 mg. A second liver biopsy at week 52 in the first 900 patients will be the basis of filing for accelerated approval under subpart H of applicable FDA regulations, which we refer to as subpart H-accelerated approval. Historically: the primary endpoint pertained to the percent of patients treated with either dose of resmetirom as compared with placebo who achieve NASH resolution on the week 52 liver biopsy, defined as the absence of hepatocyte ballooning (score=0), and minimal lobular inflammation (score 0-1), associated with at least a 2-point reduction in NAS (NAFLD Activity Score), and no worsening of fibrosis stage; and two key secondary endpoints pertained to reduction in LDL-cholesterol and a 1-point or more improvement in fibrosis stage on the week 52 biopsy with no worsening of NASH. InMay 2022 , the Company announced that it determined to move the 1-point fibrosis endpoint up the hierarchy in our MAESTRO-NASH trial to a primary endpoint along with NASH resolution, as dual primary endpoints. The dual primary endpoint design allows for a successful outcome of the study, which can be filed for subpart H approval, if either the NASH resolution or 1-point fibrosis reduction endpoint is met. Patients will continue in the study for a total of approximately 54 months, and will be evaluated for a composite clinical outcome including cirrhosis on liver biopsy, or a liver related event such as hepatic decompensation. The total anticipated enrollment currently is up to 2,000 patients, and will include up to 15% high risk F1 fibrosis stage NASH patients whose efficacy responses will be evaluated as exploratory endpoints. OnJune 30, 2021 we announced our achievement of the requisite enrollment of patients to support the planned Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) submission to theUS Food and Drug Administration (FDA).
In
key developments
MAESTRO-NAFLD-1 phase 3 additional data
InJanuary 2022 , we announced that certain primary and key secondary endpoints from the double-blind, placebo-controlled, 969-patient MAESTRO-NAFLD-1 safety study were achieved; resmetirom was well-tolerated and provided significant reductions in liver fat, LDL-c and other atherogenic lipids vs. placebo. InMay 2022 andJune 2022 , we announced additional data and results from the MAESTRO-NAFLD-1 safety study, as described below. Patients in the resmetirom 80 mg and 100 mg double-blind arms achieved reductions in ALT (p=0.002; <0.0001) relative to placebo. ALT increases ?3 times the upper limit of normal occurred in 0.61% in the resmetirom 80 mg group, 0.31% in the 100 mg group and 1.6% of patients in the placebo group. Treatment-emergent adverse events ? grade 3 in severity occurred in 7.6% of patients in the resmetirom 80 mg group, 9.0% in the 100 mg group and 9.1% in the placebo group. Withdrawals due to adverse events were 2.4% in the 80 mg group, 2.8% in the 100 mg group and 1.3% in the placebo group. GI-related adverse events (diarrhea, nausea) were increased relative to placebo at the initiation of therapy but not after the first few weeks. FibroScan CAP (controlled attenuation parameter) scores reflective of hepatic fat were statistically significantly (p<0.0001) reduced in resmetirom arms as compared with placebo. FibroScan liver stiffness reductions were similar in the 100 mg open-label and double-blind arms. Responder analyses of FibroScan (vibration-controlled transient elastography (VCTE) reduction and % reduction from baseline comparing resmetirom 100 mg open-label and double-blind arms with placebo showed a significant increase in responders in resmetirom treatment arms (44% averaged across the arms) compared with placebo (25%); magnetic resonance elastography (MRE) responders as measured by kPa reduction were significantly greater in resmetirom-treated groups compared with placebo. Mean reduction in FibroScan VCTE in resmetirom double-blind patients was greater than placebo but not statistically significant.
MAESTRO-NASH outcome study
InAugust 2022 , we initiated a second NASH outcomes study, MAESTRO-NASH Outcomes, a randomized double-blind placebo-controlled study in approximately 700 patients with early NASH cirrhosis to allow for non-invasive monitoring of progression to liver decompensation events. Several biomarker and imaging techniques will also be employed to assess correlates with disease progression. Ongoing open-label studies of more than 180 patients with well-compensated NASH cirrhosis (MAESTRO-NAFLD-1 open-label arm) support the potential of resmetirom in this patient population. 20
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We hope that a positive result in MAESTRO-NASH Outcomes could support full approval of resmetirom for non-cirrhotic NASH and could accelerate the timeline to full approval. Additionally, this study has the potential to expand the resmetirom label to include NASH patients with compensated cirrhosis.
Loan facility to support expansion of clinical development program and acceleration for potential launch of resmetirom
We secured a$250 million Loan Facility ("Loan Facility") with Hercules Capital, Inc ("Hercules") inMay 2022 . The committed capital strengthens our balance sheet, providing an additional source of funding both to support the expanded clinical program and ramp-up for a potential launch of resmetirom in theU.S. Under the terms of the Loan Facility,$50 million was drawn at closing. We may also draw up to an additional$125 million in two separate tranches upon achievement of resmetirom clinical and regulatory milestones and conditions. An additional$75 million may be drawn by us, subject to the approval of Hercules. The Loan Facility has a minimum interest rate of 7.45% and adjusts with changes in the prime rate. We will pay interest-only for a period of 30 months, which may be extended to 60 months upon the achievement of certain clinical and regulatory milestones. The loan matures inMay 2026 and may be extended an additional year upon the achievement of certain clinical and regulatory milestones.
basis of presentation
Research and development expenses
Research and development expenses primarily consist of costs associated with our research activities, including the preclinical and clinical development of our product candidates. We expense our research and development expenses as incurred. We contract with clinical research organizations to manage our clinical trials under agreed upon budgets for each study, with oversight by our clinical program managers. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received. Manufacturing expense includes costs associated with drug formulation development and clinical drug production. We do not track employee and facility related research and development costs by project, as we typically use our employee and infrastructure resources across multiple research and development programs. We believe that the allocation of such costs would be arbitrary and not be meaningful.
Our research and development expenses consist mainly of:
• salaries and related expense, including stock-based compensation;
• external expenses paid to clinical trial sites, contract research
organizations, laboratories, database software and consultants that
conduct clinical trials;
• expenses related to the development and production of non-clinical drugs and
clinical trial supplies, including fees paid to contract
manufacturers;
• expenses related to preclinical studies;
• expenses related to compliance with drug development regulations
requirements; and
• other allocated expenses, including direct and allocated expenses
for depreciation of equipment and other supplies.
We expect to continue to incur substantial expenses related to our development
activities for the foreseeable future as we conduct our clinical studies
programs, manufacturing and toxicology studies. Product candidates in later
stages of clinical development generally have higher development costs than
those in earlier stages of clinical development, primarily due to the increased
size and duration of later stage clinical trials, additional drug manufacturing
requirements, and later stage toxicology studies such as carcinogenicity
studies. Our research and development expenses have increased period over period
in each of 2022 and 2021 and we expect that our research and development
expenses will increase in the future, including as a result of our MAESTRO-NASH
Outcomes study discussed in -"Key Developments" above. The process of conducting
preclinical studies and clinical trials necessary to obtain regulatory approval
is costly and time consuming. The probability of success for each product
candidate is affected by numerous factors, including preclinical data, clinical
data, competition, manufacturing capability and commercial viability.
Accordingly, we may never succeed in achieving marketing approval for any of our
product candidates.
Completion dates and costs for our clinical development programs as well as our
research program can vary significantly for each current and future product
candidate and are difficult to predict. As a result, we cannot estimate with any
degree of certainty the costs we will incur in connection with the development
of our product candidates at this point in time. We expect that we will make
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determinations as to which programs and product candidates to pursue and how much funding to direct to each program and product candidate on an ongoing basis in response to the scientific success of research, results of ongoing and future clinical trials, potential collaborative agreements with respect to programs or potential product candidates, as well as ongoing assessments as to each current or future product candidate's commercial potential.
General and adminsitrative expenses
General and administrative expenses consist primarily of salaries, benefits and stock-based compensation expenses for employees, management costs, costs associated with obtaining and maintaining our patent portfolio, professional fees for accounting, auditing, consulting and legal services, and allocated overhead expenses. We expect that our general and administrative expenses may increase in the future as we expand our operating activities, maintain and expand our patent portfolio and incur additional costs associated with being a public company and maintaining compliance with exchange listing andSEC requirements. We expect these potential increases will likely include management costs, legal fees, accounting fees, directors' and officers' liability insurance premiums and expenses associated with investor relations.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles inthe United States . The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities as of the date of the financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued research and development expenses and stock-based compensation expense. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions. There have been no material changes in our critical accounting policies and significant judgments and estimates during the nine months endedSeptember 30, 2022 , as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 filed with theSEC onFebruary 25, 2022 .
Results of Operations
three months finished
The following table provides comparative unaudited results of operations for the three months ended
Three Months Ended September 30, Increase / (Decrease)
2022 2021 $ %
Research and development expenses
13,398 24 %
General and Administrative Expenses 12,141 8,287 3,854 47 %
Interest (Income) (717 ) (60 ) 657 1095 %
Interest Expense 1,502 - 1,502 100 %
$ 81,197 $ 63,100 18,097 29 %
Revenue
We had no income for the three months ended
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Research and development expenses
Our research and development expenses were$68.3 million for the three months endedSeptember 30, 2022 , compared to$54.9 million in the corresponding period in 2021. Research and development expenses increased by$13.4 million in the 2022 period due primarily to the additional activities related to our Phase 3 clinical trials, an increase in head count, and an increase in stock compensation expense. We expect our research and development expenses to increase as we advance our clinical and preclinical development programs for resmetirom.
General and adminsitrative expenses
Our general and administrative expenses were$12.1 million for the three months endedSeptember 30, 2022 , compared to$8.3 million in the corresponding period in 2021. General and administrative expenses increased by$3.9 million in the 2022 period due primarily to increases in commercial preparation activities, including a corresponding increase in head count, and an increase in stock compensation expense. We believe our general and administrative expenses may increase over time as we advance our clinical and preclinical development programs for resmetirom, prepare for commercialization, and expand our operating activities, which will likely result in an increase in our headcount, consulting services, and related overhead needed to support those efforts.
Interest income
Our net interest income was
Interest Expense Our interest expense was$1.5 million for the three months endedSeptember 30, 2022 , compared to$0 million in the corresponding period in 2021. The increase in interest expense was as a result of the Loan Facility we entered into with Hercules during the second quarter of 2022.
nine months ended
The following table provides comparative unaudited results of operations for the nine months ended
Nine Months Ended September 30, Increase / (Decrease)
2022 2021 $ %
Research and development expenses
22,424 15 %
General and Administrative Expenses 33,573 25,606 7,967 31 %
Interest (Income) (1,109 ) (311 ) 798 257 %
Interest Expense 2,282 - 2,282 100 %
Other (income) - (273 ) (273 ) (100 %)
$ 209,445 $ 177,297 32,148 18 %
Revenue
We had no income for the nine months ended
Research and development expenses
Our research and development expenses were$174.7 million for the nine months endedSeptember 30, 2022 , compared to$152.3 million in the corresponding period in 2021. Research and development expenses increased by$22.4 million in the 2022 period due primarily to the additional activities related to our Phase 3 clinical trials, an increase in head count, and an increase in stock compensation expense. We expect our research and development expenses to increase as we advance our clinical and preclinical development programs for resmetirom. 23
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General and adminsitrative expenses
Our general and administrative expenses were$33.6 million for the nine months endedSeptember 30, 2022 , compared to$25.6 million in the corresponding period in 2021. General and administrative expenses increased by$8.0 million in the 2022 period due primarily to increases in commercial preparation activities, including a corresponding increase in head count, and an increase in stock compensation expense. We believe our general and administrative expenses may increase over time as we advance our clinical and preclinical development programs for resmetirom, prepare for commercialization, and expand our operating activities, which will likely result in an increase in our headcount, consulting services, and related overhead needed to support those efforts.
Interest income
Our net interest income was$1.1 million for the nine months endedSeptember 30, 2022 , compared to$0.3 million in the corresponding period in 2021. The increase in interest income was due primarily to higher interest rates in 2022.
Interest expenses
Our interest expense was$2.3 million for the nine months endedSeptember 30, 2022 , compared to$0 million in the corresponding period in 2021. The increase in interest expense was as a result of the Loan Facility we entered into with Hercules during the second quarter of 2022.
Liquidity and Capital Resources
Since inception, we have incurred significant net losses and we have funded our operations primarily through the issuance of capital stock and also from Loan Facility and the proceeds from our 2016 merger transaction. Our most significant use of capital pertains to salaries and benefits for our employees, including clinical, scientific, operational, financial and management personnel, and external research and development expenses, such as clinical trials and preclinical activity related to our product candidates. We also are required to make repayments of interest and principal on our Loan Facility with Hercules, as described below. As ofSeptember 30, 2022 , we had cash, cash equivalents and marketable securities totaling$153.2 million compared to$270.3 million as ofDecember 31, 2021 , with this decrease attributable to the funding of operations, partially offset by$50.0 million drawn at closing inMay 2022 from the Loan Facility with Hercules. Our cash and investment balances are held in a variety of interest-bearing instruments, including obligations ofU.S. government agencies,U.S. Treasury debt securities, corporate debt securities and money market funds. Cash in excess of immediate requirements is invested in accordance with our investment policy with a view toward capital preservation and liquidity. We anticipate continuing to incur operating losses for the foreseeable future. Subject to the considerations noted below, our rate of cash usage will likely increase in the future, in particular to support our product development and pre-commercialization efforts. Our future long-term liquidity requirements will be substantial and will depend on many factors. To meet future long-term liquidity requirements, we will need to raise additional capital to fund our operations through equity or debt financings, collaborations, partnerships or other strategic transactions. We regularly consider fundraising opportunities and may decide, from time to time, to raise capital based on various factors, including market conditions and our plans of operation. This includes, but is not limited to, the use of a$200 million at-the-market sales agreement entered into in June of 2021, withCowen and Company, LLC (the "2021 Sales Agreement"), pursuant to which we may, from time to time, issue and sell shares of our common stock up to established limits. We may also draw on additional tranches of debt under our$250 million Loan Facility with Hercules based upon achievement of resmetirom clinical and regulatory milestones and conditions. However, there is no assurance that additional capital and financing will be available on terms acceptable to us, or at all. See "Risk Factors" in Part I, Item 1A of our Annual Report for the year endedDecember 31, 2021 and in Part II, Item I.A of our quarterly report on Form 10-Q for the period endedMarch 31, 2022 , which includes a description of the risks related to our liquidity requirements, financial position and need for capital. In addition, if such capital or financing is available, any sales of additional equity securities may result in dilution to our stockholders, and any additional debt financing may include covenants that restrict our business. Based upon our current operating plans, and the Company's cash, cash equivalents and marketable securities totaling$153.2 million as ofSeptember 30, 2022 , the Company expects, that such resources will not be sufficient to fund our operating expenses and capital requirements through the one year anniversary of the filing of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt about our ability to continue as a going concern under ASC 205-40. While management currently believes this shortfall can be addressed by future financings and capital issuances, or by delaying certain clinical studies or pre-commercialization expenses if necessary, under the requirements of ASC 205-40, management may not consider in its assessment of the Company's ability to meet its obligations for the next twelve months the potential for future capital raises through debt or equity financings, collaborations, partnerships or other strategic transactions, or management plans to reduce costs that are not considered probable under these accounting standards. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The inability of the Company to obtain sufficient funds on acceptable terms when needed: could have a material adverse effect on the Company's business, results of operations and financial condition; could result in 24
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the Company delaying, reducing or eliminating some or all of its research and development programs, clinical studies or pre-commercialization efforts; could adversely affect the Company's business prospects; and could affect the Company's ability to maintain compliance with covenants under the Loan Facility. Although the Company has been successful in raising capital and financing in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all.
loan facility
OnMay 9, 2022 , we and our wholly-owned subsidiary,Canticle Pharmaceuticals, Inc. , entered into the$250.0 million Loan Facility with the several banks and other financial institutions or entities party thereto (each, a "Lender" and collectively referred to as the "Lenders"), and Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders. Under the terms of the Loan Facility, the first$50.0 million tranche was drawn at closing. The Company may also draw up to an additional$125.0 million in two separate tranches upon achievement of certain resmetirom clinical and regulatory milestones and conditions. A fourth tranche of$75.0 million may be drawn by the Company, subject to the approval of Hercules. The Loan Facility has a minimum interest rate of 7.45% and adjusts with changes in the prime rate. The Company will pay interest-only monthly payments of accrued interest under the Loan Facility for a period of 30 months, which period may be extended to 36, 48, and 60 months upon the successive achievement of certain clinical and regulatory milestones and if the Company maintains compliance with applicable financial covenants. The Loan Facility matures inMay 2026 and may be extended an additional year upon the achievement of certain clinical and regulatory milestones. As ofSeptember 30, 2022 , the outstanding principal under the Loan Facility was$50.0 million . The interest rate as ofSeptember 30, 2022 was 10.20%. Please see "Note 6 - Long Term Debt" to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for information on the Loan Facility.
Cash flow
The following table provides a summary of our net cash flow activity (in
thousands):
Nine Months Ended September 30,
2022 2021
Net cash used in operating activities $ (166,342 ) $ (135,866 )
Net cash provided by (used in) investing activities 140,299 (20,698 )
Net cash provided by financing activities 49,114 151,734
Net increase (decrease) in cash and cash equivalents
Net cash used in operating activities was$166.3 million for the nine months endedSeptember 30, 2022 , compared to$135.9 million for the corresponding period in 2021. The use of cash in these periods resulted primarily from our losses from operations, as adjusted for non-cash charges for stock-based compensation, and changes in our working capital accounts. Net cash provided by investing activities was$140.3 million for the nine months endedSeptember 30, 2022 , compared to$20.7 million used in for the corresponding period in 2021. Net cash provided by investing activities for the nine months endedSeptember 30, 2022 consisted of$271.2 million from sales and maturities of marketable securities, partially offset by$130.7 million used in purchases of marketable securities for our investment portfolio. Net cash used in for the corresponding period in 2021 consisted of$339.4 million of purchases of marketable securities for our investment portfolio, partially offset by$318.8 million from sales and maturities of marketable securities. Net cash provided by financing activities was$49.1 million for the nine months endedSeptember 30, 2022 , compared to$151.7 million for the corresponding period in 2021. Financing activities for the nine months endedSeptember 30,2022 consisted of$50.0 million from issuance of the Loan Facility, partially offset by$0.9 million of loan issuance costs. Net cash provided by for the corresponding period in 2021 consisted of$151.2 million from net proceeds from issuances of common stock under an At The Market (ATM) sales agreement and$0.5 million from the exercise of stock options.
Contractual Obligations and Commitments
Except for the future minimum payments due on the Loan Facility with Hercules set forth in "Note 6 - Long Term Debt" to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, no significant changes to contractual obligations and commitments occurred during the nine months endedSeptember 30, 2022 , as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2021 filed with theSEC onFebruary 25, 2022 . 25
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